A ground breaking change to the status quo
The European Commission has recognised that complex medical language is a major barrier to understanding valuable information for many stakeholders, and as a result lay summaries will soon become a legal requirement for all clinical trials conducted in the European Union (EU).
The new Clinical Trial Regulation (EU No 536/2014) requires trial sponsors to provide two summaries one year after the end of the trial in the EU: a trial summary and a lay person summary.
The ultimate goal of any lay summary should be to communicate complex data and scientific concepts in a patient-friendly manner, by using simple, everyday language.
The new regulation will be accompanied by detailed guidelines on best practice for lay summaries, developed by an expert group in consultation with industry, advocacy groups and other stakeholders. These guidelines will encourage consistency in the way the new clinical summaries are presented, improving awareness and understanding among patients, trial participants and the wider public.
Structured content is essential
The guidelines emphasise the need to include information on the 10 elements stated in Annex V of the regulation. However, if appropriate, the order of the headings can be altered, categories combined, and sub-headings added. Detailed recommendations on the information that should be included for each element are provided with some suggested wording; examples of neutral, non-promotional language are also provided in Annex II of the guidance document.
Clarity of language ensures understanding
As language and literacy are key barriers to effective communication of healthcare information to the public, the expert group has taken care to offer clear recommendations on the literacy levels to aim for, how to check your summary is targeted appropriately, and the language you should use.
Patient input is encouraged
The guidelines encourage the involvement of patients, patients’ families, or patient organisations in the development and review of lay summaries, where feasible, to help ensure the information meets their needs. However, the guidelines do not provide advice on how to engage and capture their input. It may be more practical to gain input when developing your initial lay summaries, rather than for every lay summary.
What can you do now?
Clinical trial lay summaries represent an opportunity for pharma to demonstrate real, practical patient-centric activity, as well as helping to enhance public understanding of clinical trials and build trust and support for future clinical research. Why not download our essential guide to help you get started?
It's time to prepare for the lay summaries regulation!